Clinical trial · Interventional
15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial
A Prospective, Randomized Noninferiority Trial Comparing 15- and 45-minute Pringle Maneuvers During Liver Resection for Oncologic Indications.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the safety of two durations of the Pringle maneuver in adults undergoing elective liver resection for malignant tumors. The main questions it aims to answer are: Is the incidence of post-hepatectomy liver failure different between 15-minute and 45-minute Pringle maneuver durations? * Do the durations differ in operative time or intraoperative blood loss? * Researchers will compare patients randomized 1:1 to 15 minutes vs 45 minutes of Pringle clamping to see if outcomes are non-inferior between groups. Participants will: * Undergo standard oncologic hepatectomy with the assigned Pringle duration. * Receive routine perioperative assessments, including laboratory tests and clinical evaluations. * Attend follow-up visits at approximately 6 months, 1 year, and 3 years after surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
| Liver Malignant Tumors | — | UNRESOLVED | — |
| Metastases to Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pringle manouver | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 15 minute Pringle manouver with 10 minute reperfusion
- description
- Hepatic pedicle clamping for 15 minutes, followed by a 10-minute declamping period during liver transection.
- interventionNames
- Procedure: Pringle manouver
- type
- EXPERIMENTAL
- label
- 45 minute Pringle manouver with 15 minute reperfusion
- description
- Hepatic pedicle clamping for 45 minutes, followed by a 15-minute declamping period during liver transection.
- interventionNames
- Procedure: Pringle manouver
Primary outcomes (1)
- measure
- Posthepatectomy liver failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of a primary or secondary malignant liver tumor. * Age \> 18 years. * Patient deemed eligible for liver resection. * WHO performance status ≤ 2. * Ability to provide written informed consent. Exclusion Criteria: * Liver cirrhosis. * Liver dysfunction classified as Child-Pugh class B or C. * Repeat hepatectomy. * Prior ablation or chemoembolization of hepatic lesions. * Prior portal vein branch embolization. * Planned or performed ALPPS procedure. * Concomitant resection of any organ other than the gallbladder during the same operation.
References
Publications (6)
- BACKGROUNDWang HP, Hou TY, Li WF, Yong CC. Inflow control can be safely used in laparoscopic subsegmentectomy of the liver: a single-center 10-year experience. BMC Surg. 2023 Dec 6;23(1):366. doi: 10.1186/s12893-023-02282-2. PMID 38057769
- BACKGROUNDvan den Broek MA, Bloemen JG, Dello SA, van de Poll MC, Olde Damink SW, Dejong CH. Randomized controlled trial analyzing the effect of 15 or 30 min intermittent Pringle maneuver on hepatocellular damage during liver surgery. J Hepatol. 2011 Aug;55(2):337-45. doi: 10.1016/j.jhep.2010.11.024. Epub 2010 Dec 13. PMID 21147188
- BACKGROUNDDoi S, Yasuda S, Hokuto D, Kamitani N, Matsuo Y, Sakata T, Nishiwada S, Nagai M, Nakamura K, Terai T, Kohara Y, Sho M. Impact of the Prolonged Intermittent Pringle Maneuver on Post-Hepatectomy Liver Failure: Comparison of Open and Laparoscopic Approaches. World J Surg. 2023 Dec;47(12):3328-3337. doi: 10.1007/s00268-023-07201-3. Epub 2023 Oct 3. PMID 37787778
- BACKGROUNDLiu J, Wang W, Shi C, Li C, Xue F, Hu L, Wang Y, Ge R. The difference in prolonged continuous and intermittent Pringle maneuver during complex hepatectomy for hepatocellular carcinoma patients with chronic liver disease: A retrospective cohort study. Cancer Med. 2021 Dec;10(23):8507-8517. doi: 10.1002/cam4.4361. Epub 2021 Oct 18. PMID 34658153
- BACKGROUNDFagenson AM, Gleeson EM, Nabi F, Lau KN, Pitt HA. When does a Pringle Maneuver cause harm? HPB (Oxford). 2021 Apr;23(4):587-594. doi: 10.1016/j.hpb.2020.07.014. Epub 2020 Sep 12. PMID 32933844
- BACKGROUNDHuang Y, Liao A, Pu X, Yang J, Lv T, Yan L, Yang J, Wu H, Jiang L. A randomized controlled trial of effect of 15- or 25-minute intermittent Pringle maneuver on hepatectomy for hepatocellular carcinoma. Surgery. 2022 Jun;171(6):1596-1604. doi: 10.1016/j.surg.2021.11.012. Epub 2021 Dec 13. PMID 34916072